Risk of Cleft Lip and/or Palate Associated With Antiepileptic Drugs: Postmarketing Safety Signal Detection and Evaluation of Information Presented to Prescribers and Patients
| Autor: | David J. Lewis, Hans-Florian Zeilhofer, Britt-Isabelle Berg, Bita Rezaallah |
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| Rok vydání: | 2019 |
| Předmět: |
Risk
Pediatrics medicine.medical_specialty Patients Cleft Lip Health Personnel MEDLINE Pharmacy Health personnel Pharmacotherapy Pregnancy Product Surveillance Postmarketing Prescribing information Adverse Drug Reaction Reporting Systems Humans Medicine Pharmacology (medical) Maternal-Fetal Exchange Pharmacology Toxicology and Pharmaceutics (miscellaneous) Maternal-fetal exchange United States Food and Drug Administration business.industry Infant Newborn Public Health Environmental and Occupational Health medicine.disease United States Cleft Palate Anticonvulsants Female business Drugs in pregnancy |
| Zdroj: | Therapeutic Innovation & Regulatory Science. 53:110-119 |
| ISSN: | 2168-4804 2168-4790 |
| DOI: | 10.1177/2168479018761638 |
| Popis: | The aim was to analyze safety data associated with the maternal use of antiepileptic drugs in pregnancy and to assess the risk of cleft lip and/or palate (CL/P) as an outcome in the neonate. A parallel objective was to assess the completeness of the safety information concerning pregnancy exposures in the Summary of Product Characteristics (SmPCs) and the Patient Information (PI) in the USA and the UK.We analyzed individual case safety reports of CL/P associated with antiepileptic drugs in the FDA Adverse Event Reporting System. For the antiepileptic drugs with signals (EB05 ≥ 2), we reviewed Drug Analysis Prints for CL/P cases in the UK Medicines and Healthcare products Regulatory Agency (MHRA). We performed descriptive analyses of relevant SmPCs and PIs in the UK and the USA using a checklist of recommendations collected from the literature.In total 817 CL/P reports were identified for 12 antiepileptic drugs in the FDA Adverse Event Reporting System. Ten of the 12 antiepileptic drugs were associated with 156 CL/P cases in the MHRA Sentinel. Safety information concerning pregnancy was found to be more comprehensive in UK SmPCs than in the US equivalents.There is statistical disproportionality in individual case safety reports indicative of an increased risk of CL/P with 12 antiepileptic drugs studied. More studies are required to explore the association between in utero exposure to antiepileptic drugs and the risk of CL/P. There are inconsistencies between the UK and US safety labels. CL/P associated with antiepileptic drugs is an important topic and requires providing inclusive, unbiased, up-to-date information to prescribers and women of childbearing age. |
| Databáze: | OpenAIRE |
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